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Strategies & Market Trends : The Thread Formerly Known as No Rest For The Wicked -- Ignore unavailable to you. Want to Upgrade?

To: charlie mcgeehan who wrote (75786)	12/1/1999 9:17:00 AM
From: woody	Read Replies (3) \| Respond to of 90042

Charlie KIDE is looking tempting at these levels..are you still in?

To: charlie mcgeehan who wrote (75786)	12/1/1999 9:17:00 AM
From: Jules	Read Replies (1) \| Respond to of 90042

Hollis-Eden Announces Preliminary Clinical Results from Phase I/II HIV Trial In South Africa With HE2000 SAN DIEGO, Dec. 1 /PRNewswire/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH - news) today announced preliminary results from the first 13 patients treated with HE2000 in a Phase I/II HIV trial in South Africa. In this study, HE2000 administered as a monotherapy produced no serious drug-related adverse events and was generally well tolerated. In addition, reductions in viral load and increases in a number of immune markers indicative of upregulation of the patients' immune systems were seen. These early results indicate HE2000 may help the immune system to control the HIV virus in patients affected with the disease. These results are being presented this week at the 4th International Workshop on HIV, Cells of Macrophage Lineage, and other Reservoirs in Florence, Italy. HE2000 is Hollis-Eden's lead investigational compound in clinical trials for the treatment of HIV/AIDS. The compound appears to act by a novel mechanism of action that affects energy regulation in the host cell and may alter the immune system in HIV-positive patients rather than directly acting on the virus. HE2000 is part of a potentially important new investigational approach to treating HIV called immune-based therapy. The major goal of immune-based therapy is to restore and enhance host immunity against HIV and other pathogens, in order to achieve better long-term control of HIV replication and to prevent the occurrence of opportunistic infections and malignancies associated with HIV/AIDS. Richard B. Hollis, Founder, Chairman and CEO stated, ''These preliminary human clinical findings represent a significant milestone for the Company. Generating human data with a potentially new class of therapy for diseases such as HIV/AIDS is a big step forward in advancing drugs with new mechanisms of action. I am proud of our scientific team as they have shown the vision, skill and commitment necessary for exploring such a complex molecule while subsequently generating an extensive amount of both virologic and immunologic data that is helping to define the drug's mechanism of action. While still early, these results indicate HE2000 may activate a broad spectrum of immune parameters that could play an important role in new immune-based therapies. These findings will be explored further to determine whether HE2000's potential activity can be translated into patient benefits by controlling or managing disease.'' HE2000 is currently being evaluated in two Phase I/II clinical studies. The first of these studies is being conducted in South Africa in patients who are treatment naive, having received no previous anti-HIV drug therapy. The Company is also evaluating HE2000 in an ongoing Phase I/II clinical trial in the United States in patients who are failing highly active antiretroviral therapy (HAART). Preliminary results of the first 13 patients enrolled in the South African study are being presented at the Workshop in Italy. The primary goal of this study is to evaluate the safety of HE2000 at three dosing levels (50, 100 and 200mg). The protocol in this study calls for patients to receive one injection at one of these dosing levels followed one to two weeks later by five sequential daily injections at this same dosing level. Patients are then monitored over a number of months for changes in a variety of safety, virologic and immune system parameters. Those patients experiencing a virologic reduction are eligible for additional courses of therapy. Findings Nine of the 13 patients received the 50mg dose and 4 received the 100mg dose. Enrollment is continuing in all three dosing groups. To date, no drug-related serious adverse events have been observed. Mild soreness associated with the intramuscular injection has been the only side effect reported. In addition to safety parameters, because of the unique mechanism of HE2000, an extensive set of analytical measurements on a number of different immunologic and virologic markers of therapeutic activity are being evaluated in this study. Statistically significant increases in phenotypic markers for upregulation of the immune system were seen in all 13 patients. These markers include activated T cells (13/13 patients), lymphokine activated killer cells (LAK) (10/13 patients), natural killer cells (NK) and antibody-dependent cell-mediated cytotoxic cells (ADCC) (12/13 patients), as well as dendritic cells (13/13 patients). These cell types are all known to fight infectious diseases in the body. The amount of increase in each of these parameters was also significant and the effects were generally long lived. These changes in the immune system could lead to a potential beneficial effect on preventing and treating opportunistic infections in HIV/AIDS patients. The Company believes HE2000's impact on certain cytokine levels may have contributed to these changes in immune cell subsets. For example, HIV and other immunocompromised patients are known to experience an overproduction of interleukin-10 (IL-10) relative to production of interferon gamma, and this imbalance is believed to contribute to the immune system's inability to respond effectively to certain infections in these patients. To date in this study, IL-10 levels have been significantly decreased while interferon gamma levels have been maintained in 11 of 13 patients. Virologic response in the first 13 patients included an initial rise in viral titer (consistent with results from previous primate studies) followed by a decrease to below baseline values in a majority of patients. To date, a mean trough 0.96 log reduction in viral concentration was recorded for 6 of the 13 patients treated in the first two dosing groups who were classified as virologic responders (>0.50 log reduction from baseline). The mean change from baseline levels at the nadir for all patients was a decline of 0.56 log of viral load and was noted at a mean time of 69 days on protocol. These findings are consistent with the delay that would be expected from an immune-based response. Another interesting finding was that the depth and duration of the virologic response may have been partially hindered by transient increases in interleukin-2 (IL-2). IL-2 is a cytokine that is important to expansion of T cells that are central to the immune response. Because HIV infects a subset of T cells, IL-2 exposure generally results in an increase in HIV levels in blood. Presently, other researchers are exploring the potential benefits of IL-2 in managing patients with HIV. In the South African study with HE2000, a transient increase in IL-2 was seen in 10 of 13 patients and was temporally related to an increase in viral loads in these patients. No increase in IL-2 was observed in the 3 patients who did not experience an initial increase in viral load. Because of the transient short-term changes in viral load associated with dosing in most patients and a mean time of 69 days for response, the Company is modifying the protocol for this study to allow for a longer time between additional dosing regimens to determine whether further improvements in the depth and duration of virologic response and other markers may be observed. Commenting on the results, Dr. James Frincke, Executive Vice President of Research and Development for Hollis-Eden, said ''While preliminary, these results are very encouraging -- particularly those related to moving phenotypic markers in the immune system at these low doses. We look forward to completing these Phase I/II studies and conducting additional clinical trials to optimize the dosing schedule. Assuming these efforts are successful, we anticipate moving rapidly into pivotal trials.'' Dr. Thomas C. Merigan, George E. and Lucy Becker Professor of Medicine at Stanford University School of Medicine, Director of Stanford University's Center For AIDS Research and a director of Hollis-Eden said, ''This interesting data clearly differs from what is seen with traditional antiretrovirals; therefore we need further studies to fully optimize the potentially beneficial immunologic and virologic responses observed.'' Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical company based in San Diego, CA engaged in the development of products for the treatment of infectious diseases and immune system disorders. The company is currently testing its lead drug candidate, HE2000, in HIV/AIDS patients both in South Africa and the United States. HE2000 appears to act by a novel mechanism that targets the host cell and may alter the immune system in HIV-positive patients rather than directly acting on the virus. HE2000 is licensed to Hollis-Eden Pharmaceuticals from Patrick T. Prendergast and Colthurst Ltd. For more information regarding Hollis-Eden, contact the Company's website at www.holliseden.com